Antibiotic Prophylaxis for EUS-FNA of Pancreatic Cystic Lesions (PrePaCyst)

August 1, 2024 updated by: David KARSENTI, Société Française d'Endoscopie Digestive

Prevention of Infection After EUS-FNA of Pancreatic Cystic Lesions: A French Multicenter Prospective Comparative Observational Study

Large prospective comparative observational study in numerous reference centers in France, comparing infectious complications in patients admitted for pancreatic cystic lesions (PCL) aspiration performed with or without antibiotic prophylaxis (ATBp) according to the usual practices.

This is a prospective, comparative, observational, multicenter study, with the primary objective of comparing the infection rates in pancreatic cystic lesions (PCL) aspirated under EUS, with and without the administration of ATBp.

A sample size of 1702 patients will be needed over a 3-year study period.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The complication rate after EUS fine needle aspiration (EUS-FNA) for pancreatic cystic lesions (PCL) is low, around 1-3% according to various series. However, it has long been recommended to perform this procedure under antibiotic prophylaxis (ATBp). Due to the risk of developing resistance to certain classes of antibiotics and the risk of complications, particularly allergic reactions, the role of ATBp in this indication needs to be reconsidered. The latest recommendations from European and French societies do not support the systematic formal indication of ATBp for aspiration under EUS. Because the literature on the subject is sparse and equivocal, practices remain varied (some performing PCL aspirations with and others without ATBp), and scientific societies do not provide a formal stance on the benefit of such ATBp. Therefore, we decided to conduct a very large prospective comparative observational study in numerous reference centers in France (centers of the Research and Action Group in Endoscopy - GRAPHE), comparing infectious complications in patients admitted for EUS-FNA for PCL performed with or without ATBp according to the usual practices .

This is a prospective, comparative, observational, multicenter study.

Primary objective:

Comparison of infection rates after EUS-FNA for pancreatic cystic lesions (PCL) , with and without the administration of ATBp.

Secondary objectives:

Rates of other infectious complications (pulmonary, urinary, etc.) Rates of post-ATBp complications, particularly allergic reactions Prolongation of scheduled hospitalization Evaluation of factors associated with post-EUS aspiration infection of PCL

After the endoscopic exploration, the patient will be monitored for the potential occurrence of complications related to EUS (perforation, hemorrhage, infection, allergy, etc.). Any adverse events will be recorded at 30 days post-procedure.

A sample size of 1702 patients will be needed over a 3-year study period.

Study Type

Observational

Enrollment (Estimated)

1702

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with pancreatic cystic lesions for whom an EUS-FNA is indicated

Description

Inclusion Criteria:

  • Patient referred for diagnostic aspiration of a pancreatic cystic lesion
  • Patient aged 18 years or older
  • Patient with ASA 1, ASA 2, ASA 3 status
  • No participation in another concurrent clinical study

Exclusion Criteria:

  • Patient under 18 years old
  • Patient with ASA 4 or ASA 5 status
  • Pregnant woman
  • Patient with coagulation disorders preventing the performance of an EUS-FNA: PT < 50%, platelets < 50,000/mm³, current effective anticoagulation, ongoing clopidogrel, prasugrel, or ticagrelor treatment
  • Patient unable to personally express non-opposition or legally protected adult

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
EUS-FNA for PCL with ATBp
Patients undergoing EUS-FNA for pancreatic cystic lesions WITH ATBp
Procedure: EUS-FNA
Puncture of pancreatic cystic lesion with a fine needle under EUS guidance
Other Names:
  • EUS fine needle aspiration
Drug: ATBp
Antibiotic prophylaxis consists of a single intravenous administration before or at the beginning of the procedure according to the common practices of each practitioner or unit
Other Names:
  • Antibiotic prophylaxis
EUS-FNA for PCL without ATBp
Patients undergoing EUS-FNA for pancreatic cystic lesions without ATBp
Procedure: EUS-FNA
Puncture of pancreatic cystic lesion with a fine needle under EUS guidance
Other Names:
  • EUS fine needle aspiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post EUS-FNA PCL infection rate
Time Frame: 30 days
Post-EUS-FNA infection rate of PCL (patients exhibiting clinical and biological signs - fever >38.5°C, neutrophilic leukocytosis, elevated CRP, pathogen identification in blood cultures - indicative of sepsis requiring prolonged antibiotic therapy). The occurrence of the aforementioned clinical and biological signs, along with imaging evidence (such as cyst wall thickening or presence of intracystic air images) and the absence of another infection source (urinary, pulmonary, venous, etc.) will lead to the diagnosis of post-FNA infection. Centralized validation of infection cases will be conducted by an expert panel based on clinical, biological, and imaging findings.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of urinary infectious complications
Time Frame: 30 days
Number of patients with at least one urinary infection within 21-30 days after EUS-FNA
30 days
Rate of post-ATBp allergic reactions
Time Frame: 30 days
Number of patients with at least one allergic reaction within 21-30 days after EUS-FNA
30 days
Duration and extension of hospitalization
Time Frame: 30 days
Number of hospitalization days per stay within 30 days following EUS-FNA
30 days
Diameter of the needle used for EUS-FNA
Time Frame: 1 days
25G, 22G, 20G, or 19G
1 days
Associated procedures (confocal endomicroscopy or intracystic biopsy)
Time Frame: 1 days
Yes or No
1 days
Appearance of the fluid
Time Frame: 1 day
Thin, thick, hemorrhagic
1 day
Complete aspiration of the cyst fluid
Time Frame: 1 day
Yes or No
1 day
Nature of the PCL
Time Frame: 30 days
mucinous vs. non-mucinous
30 days
Age
Time Frame: 1 day
Years
1 day
Gender
Time Frame: 1 day
Male or female
1 day
Diabetes
Time Frame: 1 day
Yes or No
1 day
Immunosuppression
Time Frame: 1 day
Yes or No
1 day
BMI
Time Frame: 1 day
Weight/(size)2 expressed in in kg/m^2
1 day
history of aspiration of the same lesion
Time Frame: 1 day
Yes or No
1 day
Rate of pulmonary infectious complications
Time Frame: 30 days
Number of patients with at least one pulmonary infection within 21-30 days after EUS-FNA
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société Française d'Endoscopie Digestive

Investigators

  • Study Chair: David KARSENTI, Société Française d'Endoscopie Digestive

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 15, 2024

Primary Completion (Estimated)

September 15, 2027

Study Completion (Estimated)

October 15, 2027

Study Registration Dates

First Submitted

July 28, 2024

First Submitted That Met QC Criteria

August 1, 2024

First Posted (Actual)

August 2, 2024

Study Record Updates

Last Update Posted (Actual)

August 2, 2024

Last Update Submitted That Met QC Criteria

August 1, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SFED-165

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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